FDA's ODAC, or its oncological drug advisory committee, met on July 15, 2009, to discuss, among other matters, a request to approve a combination-therapy indication -- for advanced breast cancers -- on a drug sold worldwide, by Schering-Plough under the name of Caelyx. According to PR Canada.net, the outcome was decidedly unfavorable to Centocor-Ortho, and thus Schering-Plough:
. . . .Based on the data presented today, the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended that the combination of Doxil (doxorubicin HCI liposome injection) and docetaxel did not provide a sufficient benefit-risk profile for the treatment of women with locally advanced or metastatic breast cancer. . . .
Doxil is marketed in the United States by Centocor Ortho Biotech Products, L.P., and in Israel by Janssen-Cilag. Schering-Plough Corporation, under a licensing agreement, has exclusive rights to market the medication as Caelyx throughout the rest of the world, excluding Japan and Israel. . . .
[From the FDA's ODAC meeting materials:]
. . . .Doxil [Caelyx] is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after prior platinum-based therapy. . . . Doxil [Caelyx] is also indicated for the treatment of AIDS-related Kaposi's sarcoma in patients after failure of prior systemic chemotherapy or intolerance to such therapy. . . .
So, it is not likely that FDA will approve Caelyx -- for these expanded breast cancer indications, when the full commission next meets. It is also noteworthy that the putative benefit-to-risk profiles of a given drug, or combination -- are cited as the basis for non-approvability -- more explicitly, in the written records of FDA, of late.
4 comments:
So much for one of those 'value-enhancement' products.
But, then again, S/P did win one in the courts:
http://lawandmore.typepad.com/law_and_more/2009/07/offlabel-win-for-scheringplough-issue-is-effectiveness.html
I guess they could just push the 'off-label use' option, now that it is open to them.
I think the "win" was not unexpected -- and thus, not a "big" one, at all. . . .
That is, FDA regulates label-copy, and disciplines "off-label" promotions.
So, FDA will continue to pull its approval, as to drugs for which pharma companies intentionally, and repeatedly promote off-label -- and may even refer egregious cases to the DoJ, for civil (and perhaps, criminal) prosecution of the marketing and sales executives involved, personally.
However, going "off-label" should not automatically result in any plaintiff "winning the lottery" -- if the patient is entirely uninjured, but litigation-prone.
All this case holds is that one must prove one's actual damamges, in an "off-label" promotion case.
In any event, all patients retain various claims against their doctors -- if these patients are able to show that another course of treatment would have benefitted them more (and that their doctors did not fully-inform them of those other options).
Unless a patient is able to show the "off-label" use specifically injured them, the individual will not be able to recover from the drug company.
Said another way, if you have no injury, why should you recover?
Great comment -- do stop back!
Namaste
Oncologic Drugs Advisory Committee (ODAC) recommended that the combination of Doxil (doxorubicin HCI liposome injection) and docetaxel did not provide a sufficient benefit-risk profile.
As I read the materials it was ODAC that mentioned risk vs. benefit and not FDA. Plus it seems that in addition to toxicity there were problems in assessing efficacy so FDA wasn't even sure if a difference in efficacy was shown.
FDA has been supposed to look at benefit to risk ratio since 1961. If you look at the legislative history that was the entire reason for requiring drugs show efficacy in the first place. Unfortunately it has devolved in some therapeutic areas into if any efficacy can be shown or claimed (not even adequately shown) then it's worth any risk (even an increase in mortality).
Salmon
I agree Salmon -- but I think the "risk" equasion is making a come-back, in practice -- that was my central point.
You are right about the history -- yours certainly rings true, in my experience, going back to at least the early 1980s. . . .
Namsaste
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